Sr. Engineer I

The Sr. Engineer I provides engineering technical support and troubleshooting for clean utility systems (WPU, WFI, Clean Steam, Gases). Participates in multi-functional teams to implement changes and improvement on existing processes. This position partners with other teams including Utilities, Manufacturing, Process Engineering, Maintenance, and others to measure, target and improve reliability of all assets. Supports design, specification, installation, commissioning, and qualification of new equipment including URS and protocol writing and executions. Works with and provides direction to facilities engineers and contractors. Participates and leads large engineering projects with minimal supervision and direction. Partners with project managers to manage budgets, resources, and timelines to complete project.

What You'll Do

• Support Facility/Utility operations by troubleshooting issues and identifying equipment system improvements. Update standards, drawings, and specifications as necessary. Develop validation protocols, provide expertise to associated equipment & automation design modifications. Author deviations, CAPA’s and/or change control records in a GMP environment.
• Support equipment related capital and op-ex projects, including scoping, modifications, design reviews, change controls, construction support, commissioning, and validation.
• Develop and execute equipment commissioning and qualification (validation) activities.
• Represent department and lead/participate in cross-functional/global teams to address issues, implement change and improve existing processes.
• Manage small capital projects.

Who You Are

You are an experienced utility/facility engineer who likes to troubleshoot equipment, lead investigations and identify and implement improvements to increase system reliability, compliance and efficiency. You are also passionate about learning new technologies and working in a cross-functional environment. You are accountable for achieving milestones in equipment projects, involving frequent internal and external communication. As a representative of the Facilities Engineering organization, your role carries the weight of potential delays and extra resource allocation if errors occur in your decisions or recommendations. Your commitment lies in delivering accurate and timely results, ensuring efficient processes to prevent setbacks.

Requirements

• BS in Engineering or related discipline
• 5 years of transferrable experience.
• Practical knowledge of the application of FDA GMP and EMA regulations.
• Expert in industrial utility systems generation and distribution.
• Experience with supporting utilities including plant steam, chilled water and cooling towers, industrial air compressors.
• Basic knowledge with automation systems and Piping/Instrumentation diagrams for operation and troubleshooting.
• Competency in MS Word, MS Excel, MS Power Point MS Sharepoint and MS Project.
• Excellent oral and written communication skills.
• May be asked to work extended shifts or weekends.

Preferred Qualifications

• Capital Project management experience preferred.
• GMP facility and cleanroom design principles.
• Other support utility experience preferred.
• Experience defending clean utility procedures and practices to regulatory authorities.
• Experience in biotechnology/pharmaceutical manufacturing environment.
• Validation experience.